Reported Apr 16, 2014 · Terminated
Spiriva HandiHaler (tiotropium bromide inhalation powder), Do Not Swallow Spiriva Capsules, For Use With HandiHaler…
Boehringer Ingelheim Roxane Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Boehringer Ingelheim Roxane Inc · 1809 Wilson Rd · Columbus, OH · 43228-9579
Is this the product you have?
- Spiriva HandiHaler (tiotropium bromide inhalation powder), Do Not Swallow Spiriva Capsules, For Use With HandiHaler Only, 18 mcg (as tiotropium) per capsule, Rx Only, a) NDC 0597-0075-75, 5 Spiriva capsules per blister card, b) NDC 0597-0075-41, 30 Spiriva capsules per blister card
- Manufactured byBoehringer Ingelheim (BI) Pharma, GmbH & Co. KG, Ingelheim, Germany
- Marketed byBoehringer Ingelheim Pharmaceuticals Inc., Ridgefield, CT 06877 USA and Pfizer Inc New York, NY 10017 USA, Made in Germany
- Lot codes and dates
- a) 5 count capsule blister card
303012AExp Sep 2014
- b) 30 count capsules blister card
303012BExp Sep 2014303125A303253AExp Oct 2014303895A304282AExp Nov 2014304510AExp Dec 2014
- a) 5 count capsule blister card
- Amount recalled
- 1,276,710 Blister Cards
Where it was sold
- Nationwide
- PR
Why it was recalled
Defective Delivery System: Potential for dose delivery out of specification due to interation of the drug product powder with the lubricant on the interior of the capsule shell.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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